Clinical trial · Interventional
Bortezomib in Treating Patients With Recurrent Glioma
Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas
NCT00006773CI-TRIAL-00009093terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Brain Tumor | Adult Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib)
- description
- Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- Maximum tolerated dose of bortezomib defined as the dose level below that at which > 1 of 3-6 patients experience DLT
- timeFrame
- 3 weeks
- description
- Graded using the CTC version 2.0.
Secondary outcomes (2)
- measure
- Biological effectiveness estimated using 20S proteosome activity
- timeFrame
- Up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed progressive or recurrent malignant glioma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Prior low-grade gliomas that have progressed to high-grade after therapy allowed * Measurable disease by MRI or CT scan * Performance status - Karnofsky 60-100% * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 4 times upper limit of normal * Creatinine no greater than 1.7 mg/dL * Mini mental score at least 15 * No concurrent serious infection or other medical illness that would preclude study participation * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No more than 1 prior chemotherapy regimen * At least 3 months since prior radiotherapy and recovered * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.